Re-evaluation Of Current Status And Safety Of Danhong Injection Based On Real World In Sichuan Province

Objective:To fully understand the clinical situation of Nei Danhong injection in Sichuan Province,to evaluate the rationality;to understand the characteristics of adverse reactions of Danhong injection,to determine the risk factors,and to establish a predictive model to achieve individualized medication guidance.Methods:Real-world research on Danhong injection was carried out in 18 medical institutions in Sichuan Province.Basic information on the use of Danhong injection,information on the disease,specific adverse reactions and combined medication were collected.964 valid Danhong injection ADR reports were received indirectly from the drug SRS of the Sichuan Adverse Drug Reaction Monitoring Center from January 1,2010 to December 30,2017.After the data collated,the association rules were analyzed.While the adverse reaction cases in the study were based on nested case-control,Modeler established an adverse reaction prediction model,and the model was evaluated and verified.Result:1.The use of Danhong injection is mainly for the elderly in cardiology.The dose of patients with liver and kidney dysfunction was not different from other populations.In addition to cardiovascular and cerebrovascular diseases in the indications,some medications are hyperindications,such as diabetes,hypertension,osteoarthritis and other reasons.There are many types of drugs,mainly cardiovascular drugs such as atorvastatin and aspirin.There are many types of auxiliary medications,and clinical monitoring should strengthen.The average course of Danhong injection is 6.86 days,the average drip rate is about 45 drops/minute,most of the speed is less than 50 drops/minute,but about 40%of the population has a higher infusion rate.The average cost of Danhong injection is 823.30 yuan,and part of the cost is relatively large.2.Through the correlation analysis of ADR report of Danhong injection in SRS,the number of reported drugs has been rising in recent years,mainly for the elderly aged 60-79 years.The adverse reactions mainly occur in the skin and cardiovascular system,the disease situation will affect the time and performance of ADR;3.Match the adverse reaction cases collected in RWS in a 1:4 ratio,then use SPSS Modeler software to model,select SVC,logistic regression,and ANN models,and integrate the models,single model training set.The accuracy is 97.87%,92.55%,and 93.62%,but the accuracy of the single model test set is lower,which is 86.14%,85.15%,and 88.12%,respectively.The integration gap between the model training set and the test set is reduced.It is 95.74%and 88.12%.The prediction accuracy of the overall model can reach 91.79%without partitioning.Conclusion:There are still unreasonable places in the clinical use of Danhong injection,which are manifested in the treatment of super-indications,excessive infusion rate,and choice of solvent.The basic conditions and disease status of patients will affect the time and performance of ADR.The accuracy of the model is high.The generalization ability of the single model in modeling is not as good as the overall model.The risk factors for the adverse reactions of Danhong injection are infusion rate,connective tissue disease and comorbidity index.